Magazine article Drug Topics

Partial Refill, Investigational Drugs Subjects for Compliance Concerns

Magazine article Drug Topics

Partial Refill, Investigational Drugs Subjects for Compliance Concerns

Article excerpt


Partial prescription refills and billing for drugs used in clinical trials were among the subjects raised at this year's Fraud & Compliance Forum sponsored by the American Health Lawyers Association and the Health Care Compliance Association.

The big news was Inspector General Janet Rehnquist's release of a draft version of her office's "Compliance Program Guidance for Pharmaceutical Manufacturers." Published in the Federal Register on Oct. 3, it offers guidance to drugmakers on how to properly market their drugs to healthcare providers and how to set up a compliance program to be sure that employees are following the rules.

Rehnquist said such guidance should be welcome in an era where many corporate executives are being called on the carpet for malfeasance. "This compliance program creates internal checks and balances that can apply throughout the corporation, not just in the healthcare piece," she said. "It enhances the corporation's reputation for integrity."

However, Mary Reardon, senior counsel in the IG's Office of Counsel, said in a briefing following Rehnquist's talk that retail pharmacies and pharmacy benefit management companies were deliberately excluded from the guidance report because "their [issues] are different, and we wanted to keep the focus on manufacturers."

The IG's office does not have any plans to issue a separate guidance for retail pharmacies and pharmacy benefit managers, although the office is not ruling it out for the future, she said. One of the issues that has come up at the retail pharmacy level is how to handle partial refills, which were the subject of a recent government action against the Walgreen pharmacy chain. In that case, which resulted in the pharmacy's payment of $7 million to settle the matter, Walgreen's was accused of billing the government for full refills of patient prescriptions when it had actually only partially refilled them.

Another area of interest was how to properly bill the government for drugs used in clinical trials. The national coverage decision issued in September 2000 by the Centers for Medicare & Medicaid Services authorized CMS to pay for the costs of health care for Medicare patients during routine clinical trials. …

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